– We have a very exciting year ahead of us, says Xintela CEO Evy Lundgren-Åkerlund in an interview with BioStock.
Xintela develops drugs in both stem cell therapy and cancer therapy that are based on a marker technology platform based on the cell surface marker integrin α10β1. In stem cell therapy, this marker is used to select and quality assure stem cells, which forms the basis for stem cell products XSTEM — which targets the treatment of osteoarthritis and difficult-to-heal wounds — and EQSTEM, for the treatment of joint disease in horses. Xintela produces stem cells for clinical studies in its own GMP-certified facility in Lund, where the company also conducts its other operations.
Subsidiary Targinta further develops the potential of integrin α10β1 by using it as a target molecule for antibody-based drugs for the treatment of aggressive cancers.
Approaching interim data in the osteoarthritis study
Xintela has been conducting a Phase I/IIa clinical trial of XSTEM in Australia for a year and a half, targeting patients with moderate knee osteoarthritis. The study includes three different dose levels of XSTEM being evaluated in 24 patients, with the possibility of expanding to a total of 54 patients.
In Q1 2025, Xintela plans to present an interim analysis evaluating both safety and multiple efficacy parameters, based on the 18-month follow-up for all three dose levels. Patients treated with the highest dose level will be followed for an additional 6 months to collect additional efficacy data 24 months after treatment.
Previous results from the study show that the treatment is safe and patients report reduced pain and improved joint function after 12 months. The goal is to demonstrate a disease-modifying osteoarthritis drug (DMOAD) effect by slowing cartilage and joint degradation and promoting regeneration of damaged articular cartilage and other tissues in the joint.
If Xintela successfully establishes proof-of-concept in the osteoarthritis study, the next step is to enter into a partnership and out-license XSTEM for continued clinical development.
Study on difficult-to-heal wounds and licensing discussions for EQSTEM
At the same time, a clinical study with XSTEM is underway on patients with difficult-to-heal venous leg ulcers at a skin clinic in Gothenburg. Four patients have been dosed, of which three have completed the study as planned after four months. The study has not shown any safety issues, and now patient recruitment and planning for the next stage of development continue.
In parallel, collaboration and licensing discussions are being held with EQGen Biomedical in the US for the clinical development and commercialization of EQSTEM for horses. In 2024, Xintela entered into a non-binding term sheet that provides EQGen Biomedical global rights to EQSTEM in a future license agreement. EQGen is currently working to secure financing to complete the license agreement and begin development work.
Strengthened cash flow through TO and assignment agreements
Xintela has also recently strengthened its cash position by SEK 29,1 million through the exercise of warrants of series TO3. The company's largest owner, Flerie Invest, subscribed all of their options during the redemption period and thus contributed significantly to the capital injection.
In 2024, Xintela has also received revenue through a new assignment agreement with Region of ÖstergötlandThe agreement is worth SEK 3,6 million and concerns the development of a GMP process for the isolation and quality assurance of autologous skin cells for the treatment of burn patients.
The next step in the collaboration with Region Östergötland is to manufacture skin cell preparations from patient biopsies in Xintela's GMP facility under another contract.
CEO sums up the year
BioStock contacted Xintela's CEO Evy Lundgren-Åkerlund to learn more about progress in 2024 and upcoming milestones in 2025.
Now that we have left 2024 behind us, how would you summarize the past year for Xintela? What milestones are you most proud of?
– It has been an intense and eventful year with a lot of focus on our clinical studies with XSTEM. I am especially proud that we have simultaneously received significant revenue through the assignment agreement with Region Östergötland and that we have ongoing licensing discussions with EQGen Biomedical regarding the equine product EQSTEM.
»It has been an intense and eventful year with a lot of focus on our clinical studies with XSTEM.«
An interim analysis from the osteoarthritis study is just around the corner. What do you hope it will show, and how does it affect the next steps for XSTEM?
– The primary goal of the study is to show that XSTEM is safe but also to evaluate various efficacy parameters. We have already shown safety, three months after treatment with XSTEM for all three dose levels, and hope that the analysis will also show a positive effect of the treatment. The results will form the basis for the design of the next step in the clinical development work and also for the work of landing a partner and licensee.
What do the discussions with EQGen Biomedical mean for EQSTEM, and what is the timeline for a potential licensing agreement?
– We ourselves do not have the opportunity to simultaneously finance and develop XSTEM and EQSTEM. It is therefore very positive that we have collaborative discussions with EQGen Biomedical who are enthusiastic about continuing the development of EQSTEM into a finished product for horses. EQGen is a newly formed company so there is a lot that needs to fall into place before the work with EQSTEM. We are involved in that work and we have come a long way in the contract discussions.
– We now look forward to landing the license agreement and getting started with the first planned assignment for Xintela to develop a GMP (Good Manufacturing Practice) process to produce EQSTEM for clinical studies.
You have established an initial collaboration for the production of advanced therapy medicinal products (ATMPs). How do you assess the potential for additional manufacturing agreements and future revenue streams?
– The next possible assignment is in the planned collaboration with EQGen Biomedical for process development and production of EQSTEM. We expect to land additional CDMO agreements in the future and continue to generate revenue for Xintela.
»We expect to land additional CDMO agreements in the future and continue to generate revenue for Xintela.«
What are the development plans for Targinta's drug candidates TARG9 and TARG10?
– Right now, the development of TARG9 and TARG10 is at a slow pace.
– We continue to work to find funding and/or partners for our exciting cancer project. We are receiving positive feedback on our unique cancer target and our first-in-class antibodies and ADCs, and continue to strengthen the preclinical documentation in parallel with business development activities.
Finally, what goals have you set for 2025?
– We have a very exciting year ahead of us. An interim analysis of 18-month data from all three dose levels of XSTEM in our knee osteoarthritis study is planned for March and a final report, which will also include 24-month data from the highest dose level of XSTEM, is planned for September.
– We also expect to take important steps forward in the development work with XSTEM for the treatment of difficult-to-heal wounds. Other important goals are to land the agreement with EQGen Biomedical, find a good path forward for our cancer antibodies and, not least, to continue generating revenue through our GMP facility and CDMO operations.